AnemiaNCT01208363
Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study
A study testing Cowpea fortified with NaFeEDTA, in form of Toubani. in people with Anemia and Low Iron Stores, run by Wageningen University at 1 site in Ghana.
Trial summary
Rationale: Iron deficiency and zinc deficiency, are of public health significance in sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer from anaemia, half of which is estimated iron deficiency anaemia. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Low Iron Stores
- What is being tested?
- Cowpea fortified with NaFeEDTA, in form of Toubani.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGhana
- Study dates
- Sep 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 6-12 years old
- Regularly attending school, in grades 1-3
- Apparently healthy, free of chronic illnesses and not taking chronic medication.
- No medication nor supplemental iron at time of entry into the study
- Informed consent obtained from at least one parent or guardian
Who cannot join
- Children with severe anemia (Hb<70 g/l).
Trial locations and contacts
1 site in 1 country.
Ghana1 site
Department of Community Nutrition, University for Development Studies
Tamale
About this study
Rationale: Iron deficiency and zinc deficiency, are of public health significance in sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer from anaemia, half of which is estimated iron deficiency anaemia. Interventions have been designed and implemented over the years towards solving hunger and anaemia especially among school age children. One of such interventions is School Feeding Programme (SFP) which is common in both developing and industrialized countries. SFP has been part of the Ghanaian educational system for well over 40 years, albeit on small scale. The main stay of the programme that makes it distinguishable from other past and existing school feeding programmes is its reliance on locally produced and available foods, such as cowpeas. Legume staples like cowpea have been identified to be important sources of protein and non-heme iron to rural populations of developing countries like Ghana. The problem however is the low bioavailability of these micronutrients from these legumes.
Objective: To assess the efficacy of iron fortified cowpea based meal (Tubani) in improving iron status of primary school children in rural northern Ghana Study design: A randomized double blind parallel design will be conducted. One group will receive iron fortified Tubani with NaFeEDTA and the other group will receive unfortified Tubani.
Read more
Study population: Two hundred and forty apparently healthy pupils in lower primary school will participate. The participating schools have a school feeding programme currently in operation.
Intervention (if applicable): Children will be fed Tubani containing 10mg of fortification iron (in the form of NaFeEDTA) three times in a week for six months. Weight, height and blood samples will be measured at baseline and after six months of intervention. Participants will be treated against intestinal parasites before start of intervention and halfway through the intervention.
Main study parameters/endpoints: The main study endpoint is iron-deficiency anaemia (IDA). IDA will be defined as concurrent anaemia and iron deficiency. Whole blood will be collected for the analysis of Hb, serum ferritin (SF), serum transferring receptor (sTfR) and C-reactive protein (CRP). Anemia will be defined as a hemoglobin concentration <115 g/L, and iron deficiency will be defined as an SF concentration <12 µg/L.
Venipunctures occasionally lead to bruises or small local inflammation which usually disappear within one week. To minimize this risk, blood collection will be performed by a trained and experienced phlebotomists. Written informed consent will be obtained from all subjects.
- Conditions
- Anemia, Low Iron Stores
- Being tested
- Cowpea fortified with NaFeEDTA, in form of Toubani.
- Keywords
- Iron fortification, polyphenols, NaFeEDTA, cowpea, school feeding program
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cowpea fortified with NaFeEDTA, in form of Toubani.Dietary supplement
66g raw Cowpea fortified with 10 mg Fe as NaFeEDTA, in form of Toubani, a cowpea snack. Ther snack will be given to the participants 3 times per week, for six month integrated in the school feeding trial.
| Study group | Role | What they receive |
|---|---|---|
| Unfortified Toubani | No intervention | Children in the school will receive, 3 times per week 66g of raw unfortified (no added Fe) cowpea in form of Toubani (a cowpea based snack). Receives: Dietary Supplement: Cowpea fortified with NaFeEDTA, in form of Toubani. |
| Fortified Cowpea | Active comparator | Study subjects will receive 3 times per week, as part of the school feeding programme 66g of raw fortified cowpea (with added 10mg Fe as NaFeEDTA)in form of Toubani (a cowpea based snack). Receives: Dietary Supplement: Cowpea fortified with NaFeEDTA, in form of Toubani. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron deficiency anemia, defined by Hb<115 g/l; SF<12 microgram/l
Autcome parameters are Hemoglobin (Hb), Serum Ferritin (SF), Serum Transferrin Receptor (sTfR), and C - Reactive protein (CRP). Prevalence of iron deficiency anemia will be calculated based on the umber of subjects with Hb<115 g/l; SF<12 microgram/l.
Measured: Duration will be 6 months. Measurements will be performed at start and after 6 months of intervention.
Secondary outcomes (1)
Serum Transferrin Receptor
Measured: 6 months, measurements will be done at start and at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Noguchi Memorial Institute for Medical Research, Nestlé Foundation
- Responsible party
- Sponsor
- Investigators
- Abdul R Abizari, Msc, Principal investigator, Division of Human Nutrition, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208363
- Sponsor's protocol ID
- COWPEA
- Other IDs
- WUR10/13
- Status last verified
- Mar 2011
- First submitted
- 22 Sep 2010
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Abizari AR, Moretti D, Zimmermann MB, Armar-Klemesu M, Brouwer ID. Whole cowpea meal fortified with NaFeEDTA reduces iron deficiency among Ghanaian school children in a malaria endemic area. J Nutr. 2012 Oct;142(10):1836-42. doi: 10.3945/jn.112.165753. Epub 2012 Aug 22.
PubMed 22915294
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study
- ClinicalTrials.gov ID
- NCT01208363
- Acronym / sponsor ID
- COWPEA
- Conditions
- Anemia, Low Iron Stores
- Keywords
- Iron fortification, polyphenols, NaFeEDTA, cowpea, school feeding program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Noguchi Memorial Institute for Medical Research, Nestlé Foundation
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Iron deficiency and zinc deficiency, are of public health significance in sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer from anaemia, half of which is estimated iron deficiency anaemia. Interventions have been designed and implemented over the years towards solving hunger and anaemia especially among school age children. One of such interventions is School Feeding Programme (SFP) which is common in both developing and industrialized countries. SFP has been part of the Ghanaian educational system for well over 40 years, albeit on small scale. The main stay of the programme that makes it distinguishable from other past and existing school feeding programmes is its reliance on locally produced and available foods, such as cowpeas. Legume staples like cowpea have been identified to be important sources of protein and non-heme iron to rural populations of developing countries like Ghana. The problem however is the low bioavailability of these micronutrients from these legumes.
Objective: To assess the efficacy of iron fortified cowpea based meal (Tubani) in improving iron status of primary school children in rural northern Ghana Study design: A randomized double blind parallel design will be conducted. One group will receive iron fortified Tubani with NaFeEDTA and the other group will receive unfortified Tubani.
Study population: Two hundred and forty apparently healthy pupils in lower primary school will participate. The participating schools have a school feeding programme currently in operation.
Intervention (if applicable): Children will be fed Tubani containing 10mg of fortification iron (in the form of NaFeEDTA) three times in a week for six months. Weight, height and blood samples will be measured at baseline and after six months of intervention. Participants will be treated against intestinal parasites before start of intervention and halfway through the intervention.
Main study parameters/endpoints: The main study endpoint is iron-deficiency anaemia (IDA). IDA will be defined as concurrent anaemia and iron deficiency. Whole blood will be collected for the analysis of Hb, serum ferritin (SF), serum transferring receptor (sTfR) and C-reactive protein (CRP). Anemia will be defined as a hemoglobin concentration <115 g/L, and iron deficiency will be defined as an SF concentration <12 µg/L.
Venipunctures occasionally lead to bruises or small local inflammation which usually disappear within one week. To minimize this risk, blood collection will be performed by a trained and experienced phlebotomists. Written informed consent will be obtained from all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unfortified Toubani | No intervention | Dietary Supplement: Cowpea fortified with NaFeEDTA, in form of Toubani.Children in the school will receive, 3 times per week 66g of raw unfortified (no added Fe) cowpea in form of Toubani (a cowpea based snack). |
| Fortified Cowpea | Active comparator | Dietary Supplement: Cowpea fortified with NaFeEDTA, in form of Toubani.Study subjects will receive 3 times per week, as part of the school feeding programme 66g of raw fortified cowpea (with added 10mg Fe as NaFeEDTA)in form of Toubani (a cowpea based snack). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children 6-12 years old
- Regularly attending school, in grades 1-3
- Apparently healthy, free of chronic illnesses and not taking chronic medication.
- No medication nor supplemental iron at time of entry into the study
- Informed consent obtained from at least one parent or guardian
Key exclusion criteria (1 listed)
- Children with severe anemia (Hb<70 g/l).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cowpea fortified with NaFeEDTA, in form of Toubani.66g raw Cowpea fortified with 10 mg Fe as NaFeEDTA, in form of Toubani, a cowpea snack. Ther snack will be given to the participants 3 times per week, for six month integrated in the school feeding trial. | Dietary supplement | Fortified Cowpea, Unfortified Toubani |
Primary outcome
Iron deficiency anemia, defined by Hb<115 g/l; SF<12 microgram/l
Time frame: Duration will be 6 months. Measurements will be performed at start and after 6 months of intervention.
Autcome parameters are Hemoglobin (Hb), Serum Ferritin (SF), Serum Transferrin Receptor (sTfR), and C - Reactive protein (CRP). Prevalence of iron deficiency anemia will be calculated based on the umber of subjects with Hb<115 g/l; SF<12 microgram/l.
1 secondary outcome
Serum Transferrin Receptor
Time frame: 6 months, measurements will be done at start and at the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
- Derived from this study: PubMed 22915294Abizari AR, Moretti D, Zimmermann MB, Armar-Klemesu M, Brouwer ID. Whole cowpea meal fortified with NaFeEDTA reduces iron deficiency among Ghanaian school children in a malaria endemic area. J Nutr. 2012 Oct;142(10):1836-42. doi: 10.3945/jn.112.165753. Epub 2012 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul R Abizari, Msc principal investigator
Division of Human Nutrition, Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cowpea fortified with NaFeEDTA, in form of Toubani. in people with Anemia and Low Iron Stores, run by Wageningen University at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron deficiency anemia, defined by Hb<115 g/l; SF<12 microgram/l (time frame: Duration will be 6 months. Measurements will be performed at start and after 6 months of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01208363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2011.